(85 days)
The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.
single patient, single use, stainless steel needle introducers with splittable sheaths, intended to facilitate the placement of Peripherally Inserted Catheters (PICs). Additionally the Safe-T-Peel® Safetv Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191).
The provided text describes a 510(k) summary for the HDC Corporation's Safe-T-Peel® Safety Needle/Introducer. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as would be found in a clinical trial or a specific standalone performance assessment.
Therefore, many of the requested elements (acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone study, ground truth type, training set size, training set ground truth establishment) cannot be directly extracted from the provided text for a performance study as typically understood for AI/algorithm-based devices.
However, based on the principle of substantial equivalence, the "acceptance criteria" here is that the device performs similarly to the predicate devices, particularly regarding safety features. The "study" proving this comes in the form of comparing the device's characteristics and functionality to those of already approved predicate devices.
Here's an attempt to address the prompt based on the available information, highlighting what can and cannot be provided:
Acceptance Criteria and Study for HDC Corporation's Safe-T-Peel® Safety Needle/Introducer
The provided 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with explicit acceptance criteria and quantitative results for device performance against a predefined metric. For a 510(k) submission of this nature, the "acceptance criteria" revolve around demonstrating that the new device has the same intended use, similar technological characteristics, and comparable safety/performance to the predicate devices. The "study" involves a comparative analysis of these attributes.
1. Table of Acceptance Criteria and Reported Device Performance
As a 510(k) submission seeking substantial equivalence for a medical device rather than a software algorithm, explicit "acceptance criteria" in terms of sensitivity, specificity, or similar statistical metrics are not provided in this document. Instead, the acceptance criteria relate to structural and functional similarity to predicate devices, particularly for safety features.
| Criteria Category | Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|---|
| Intended Use | Same primary and secondary intended uses as predicate devices. | "The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick." |
| "The primary intended use is nearly identical to the primary intended use of Becton Dickinson's INTROSYTE Autoguard Shielded Introducer (K013304), TFX Corporation's TFX Medical Introducer Assembly (K993191), and TFX Corporation's TFX Modical Safety Needle with Introducer (K000665). The secondary intended use (protection against needle stick injury) is nearly identical to that of both the K013304 and K000665 predicate devices." | ||
| Technological Characteristics | Similar design and components, especially for the splittable sheath and sharps injury prevention mechanism. | "The Safe-T-Peel® Safety Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191)." |
| "The sharps injury prevention mechanism is essentially identical to the mechanism used in Becton Dickinson's INTROSYTE Autoguard Shielded Introducer (K013304)." | ||
| Principle of Operation | Similar method of facilitating catheter placement and mechanism for sharps injury prevention. | "The Safe-T-Peel® Safety Needle/Introducer is substantially equivalent to the previously cleared predicate device (K013304) with sharps injury prevention features because it has the same intended uses, similar principles of operation, similar technological characteristics and similar performance test results." |
| Safety/Performance | Comparable safety and performance to predicate devices (e.g., in preventing needlestick injuries, material compatibility, functional integrity). | "similar performance test results" (This statement is made, but specific detailed test results are not provided in the summary, as is common for 510(k) where detailed test reports are submitted separately) |
2. Sample size used for the test set and the data provenance
Not applicable/provided. This device is a physical medical device, not an AI/algorithm. The "test set" for substantial equivalence is the comparison against the characteristics and performance of the predicate devices. The data provenance would be the design specifications and testing data of the device itself and of the predicate devices, which are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided. The concept of "ground truth" established by experts for a test set (as typically used for AI/algorithm evaluation) does not apply directly to this 510(k) summary for a physical medical device. The "truth" here is established by regulatory approval of the predicate devices and the demonstration of equivalence through design and performance testing (not detailed in this summary).
4. Adjudication method for the test set
Not applicable/provided. See explanation for point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical safety needle/introducer, not an AI/algorithm-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical safety needle/introducer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this device submission, the "ground truth" is effectively the established safety and efficacy of the predicate devices, against which the new device is compared to demonstrate substantial equivalence, based on design features, materials, and functional testing.
8. The sample size for the training set
Not applicable. This is a physical medical device. There is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
Not applicable. See explanation for point 8.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).